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FDA last month issued a formal guidance on clinical studies and trials for neurothrombectomy devices, but the guidance may simply be a formal statement of long-standing informal agency policy.
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Wanda Moebius has been named VP of policy communications of AdvaMed (Washington). Moebius most recently served as senior director of communications at the Pharmaceutical Research and Manufacturers of America.
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Just 60 days after submitting its application, Spectranetics (Colorado Springs, Colorado) last month received FDA clearance for its Turbo-Booster product treatment of arterial stenoses and occlusions in the leg, a broader indication for use as compared to current labeling of the existing peripheral laser catheters, the company said.
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St. Jude Medical (St. Paul, Minnesota) reported it has received FDA clearance of the 7F Proxis embolic protection system.
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According to the American Heart Association (Dallas), 57,000 people in the United States die every year from congestive heart failure (CHF), but only slightly more than 2,000 hearts are available annually for transplant. Serving as a potential lifeline to the 55,000 on the waiting lists are ventricular assist devices (VADs) ... and artificial hearts.
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A study is being launched by Abbott Vascular (Redwood City, California) to examine the specific effects of drug-eluting stents (DES) in women — and as an additional benefit to the company, providing more evidence concerning its Xience stent, currently under PMA review by the FDA.
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Wasting little time in harvesting the fruits of a hard-won recommendation-to-approve vote by the FDA circulatory systems advisory panel last month, CryoCor (San Diego) reported a development deal the with Boston Scientific (Natick, Massachusetts) the day after that panel decision.
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ev3 (Plymouth, Minnesota) and FoxHollow Technologies (Redwood City, California) last month unveiled a plan to merge in a $780 million cash and stock transaction, the company citing the deal as producing “greater critical mass and revenue-generating opportunities.
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CardioVations (Somerville, New Jersey), last month launched its Port Access Precision Series, a new line of surgical instruments for use in minimally-invasive heart valve repair.
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A study released last month by Frost & Sullivan (London) indicates that the Eastern European cardiac rhythm management (CRM) devices market is expanding slowly.
